Quality Assurance Specialist – External Manufacturing

4 weeks ago

Dublin, Dublin City, Ireland PSC Biotech Corporation Full time
Quality Assurance Specialist – External Manufacturing (Remote)
  • Industry: Pharma/Biotech/Clinical Research
  • Work Experience: 4-5 years
  • Location: Dublin, Ireland
Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading biotech consultancy founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US. We serve over 350 clients across more than 23 countries, providing cloud-based software solutions for quality management and regulatory inspections, contract manufacturing professionals, and metrology services.

Our Mission

PSC Biotech aims to disrupt the conventional consultancy model by offering a unique Employee Value Proposition (EVP), which includes opportunities to work with talented professionals in the pharma/biotech industry. We offer permanent contracts, providing exposure to top pharmaceutical clients in diverse cultural settings.

Employee Value Proposition

We prioritize career development through in-house training, mentorship, and guidance to facilitate growth. Our teams strive to exceed client expectations while maintaining quality, budget, and timelines.

Overview

  • Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide, creating a reliable global manufacturing network.
  • The Quality Assurance group ensures all products meet high standards and regulatory requirements, overseeing manufacturing, testing, packaging, storage, and distribution.
  • The Specialist – External Quality Vaccines acts as Product Quality Manager (PQM), ensuring products managed by External Quality Assurance are manufactured, packaged, analyzed, released, stored, and distributed per standards and regulations. This includes batch release responsibilities and on-site supervision of external partners.

This is a 6-month contract role.

Requirements

Role Functions:

  • Evaluate and/or release products, ensuring conformance to policies and regulations.
  • Review and approve change controls.
  • Manage deviations and complaints, coordinate investigations.
  • Support process validation, review validation reports, and assist with regulatory documentation.
  • Manage stability programs and review stability reports.
  • Provide guidance on metrics, procedures, and guidelines.
  • Monitor external partner performance and develop CAPA plans.
  • Maintain retention samples and support regulatory filings.

Experience, Knowledge & Skills:

  • Experience in pharmaceutical quality systems and regulatory requirements.
  • Problem-solving skills and ability to work independently.
  • Strong communication skills in English.
  • Knowledge of external manufacturing management and supply chain.

Preferred Experience and Skills:

  • Experience with biologics/vaccines manufacturing, aseptic processes.
  • Qualification of manufacturing facilities/equipment.
  • Analytical method validation and quality risk management.

Qualifications & Education:

  • Bachelor's or Master's in Science, Engineering, or related field.
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